Career Path: How to Become Drug Safety Professional?
Very few careers in pharmaceuticals have the growth potential as in drug safety. We will explore as to how to become a drug safety professional.
This article will answer common questions you may have in regards to a career in drug safety.
- Am I qualified to become a drug safety professional?
- What are the benefits of securing a career in drug safety?
- Who will hire me as a drug safety professional?
- What are the job titles in drug safety?
- Who will hire me?
- What next to become a drug safety professional?
Basic terms in Pharmacovigilance
- Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
- Adverse drug reaction is a side effect (non intended reaction to the drug) occurring with a drug where a positive (direct) causal relationship between the event and the drug is thought, or has been proven, to exist.
- Adverse event (AE) is a side effect occurring with a drug. By definition, the causal relationship between the AE and the drug is unknown.
- Benefits are commonly expressed as the proven therapeutic good of a product but should also include the patient’s subjective assessment of its effects.
- Causal relationship is said to exist when a drug is thought to have caused or contributed to the occurrence of an adverse drug reaction.
- Clinical trial (or study) refers to an organised program to determine the safety and/or efficacy of a drug (or drugs) in patients. The design of a clinical trial will depend on the drug and the phase of its development.
The activities involved in pharmacovigilance are:
- ICSR reporting which includes
- Coding of adverse events,
- Seriousness determination
- Causality assessment
- Expedited reporting
- E2B transmission.
Two main types of ICSR reporting
- Clinical trial reporting
- Spontaneous reporting
Aggregate reporting
Aggregate reporting, also known as periodic reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR).
Risk management
Risk management is the discipline within pharmacovigilance that is responsible for signal detection and the monitoring of the risk-benefit profile of drugs.
Signal detection
The WHO defines a safety signal as: “Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously”. Usually, more than a single report is required to generate a signal, depending upon the event and quality of the information available.
Risk management plans
A risk management plan (RMP) is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on the drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or pharmacist and/or the manufacturer of the drug and/or the FDA, EMA)). The overall goal of an RMP is to assure a positive risk-benefit profile once the drug is (has been) marketed.
Pharmacoepidemiology
Pharmacoepidemiology is the study of the incidence of adverse drug reactions in patient populations using drug agents.
Pharmacogenetics and pharmacogenomics
Although often used interchangeably, there are subtle differences between the two disciplines. Pharmacogenetics is generally regarded as the study or clinical testing of genetic variation that gives rise to differing responses to drugs, including adverse drug reactions. It is hoped that pharmacogenetics will eventually provide information as to which genetic profiles in patients will place those patients at greatest risk, or provide the greatest benefit, for using a particular drug or drugs. Pharmacogenomics, on the other hand, is the broader application of genomic technologies to new drug discovery and further characterization of older drugs.
Am I qualified to become a drug safety professional?
- Medical graduates with MBBS, MD, DO, Ph.Ds’,
- Dental graduates with BDS, MDS, DMD, DDS,
- Pharmacy graduates with B.Pharm, PharmD, Ph.D.,
- Majors in biological Sciences/Life Sciences/allied health fields.
- QA/QC in pharmaceuticals.
- Pre-med students
Why Should You Opt for Pharmacovigilance as Your Career?
Compensation, work-life balance, appreciation, peer collaboration, team work, stability, career growth, and cause bigger than themselves, etc are some of the parameters that make drug safety a successful and lucrative career.
For more information, check this article – http://www.medipharmsolutions.com/blog/top-five-reasons-to-choose-drug-safety-as-a-career-in-pharmaceuticals
What are the job titles in drug safety?
- Drug Safety Associate
- Safety officer
- Safety Manager
- Clinical safety scientist
- Triage Manager
- Medical Coder
- Aggregate report specialist
- Safety Physician
- Pharmacovigilance lead
- Safety lead
- Pharmacovigilance manager
- Compliance manager
- Medical safety writer
- Associate medical director
- Medical director
Career Growth in pharmacovigilance
At a fresher level, you will be hired as a Drug Safety Associate who primarily engages in case triage, creation, narrative and scientific writing, medical coding.
As you develop an understanding of ICH/GCP guidelines and regulatory practices, you will develop your scientific review of adverse events to become a Safety Scientist.
Based on your experience in a particular set of activities , you can become an aggregate report scientist or risk management specialist or signal detection scientist or a medical reviewer if you are a medical graduate.
In 6-8 years, individuals end up attaining the position of an Associate Director, Director or Vice-president, based on their organizational needs and their contribution.
Who Hires Pharmacovigilance Professionals
People trained in Pharmacovigilance can find excellent employment options in the following organizations:
- Pharmaceutical Companies.
- Contract Research Organizations (CROs).
- Biotech companies.
- Knowledge Process Outsourcing (KPOs).
- Regulatory Authorities.
- Research organizations.
What next to become a drug safety professional?
- Medipharm solutions provide the training necessary to assist professionals in bridging the gap between their qualifications and skills needed to secure a career in the pharmaceutical industry. The Institute offers this by focusing attention on deploying cutting edge training and testing certification methods. Empowering professionals with the current market place needs by building industry-standard course curriculum. Most important of all, to make you a trained professional with job-readiness skills and knowledge.
- Our course coaches who designed this curriculum are pharmacovigilance leaders in the pharmaceutical world who are passionate about guiding you in your drug safety career path.
- Failing to plan is planning to fail. So take your first step towards a life-changing career at
